Oral care implement

ABSTRACT

An oral care implement comprising tooth cleaning elements and a tissue cleanser. In one aspect, the invention can be an oral care implement comprising: a head and a handle; a plurality of tooth cleaning elements extending from a first face of the head; a receiving cavity formed into a second face of the head opposite the first face; and a soft tissue cleanser formed of an elastomeric material positioned within the receiving cavity, the soft tissue cleanser comprising a base surface that is flush with the second face of the head and a plurality of projections extending beyond the second face of the head.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patent application Ser. No. 13/965,693, filed Aug. 13, 2013, now allowed, which is a continuation of U.S. patent application Ser. No. 13/116,735, filed May 26, 2011, now U.S. Pat. No. 8,522,386, issued Sep. 3, 2013, which is a continuation of U.S. patent application Ser. No. 11/932,010, filed Oct. 31, 2007, now U.S. Pat. No. 7,950,100, which is a divisional application of U.S. patent application Ser. No. 11/566,479, filed Dec. 4, 2006, now U.S. Pat. No. 7,322,067, which is a divisional application of U.S. patent application Ser. No. 10/869,922, filed Jun. 18, 2004, now U.S. Pat. No. 7,143,462, which is: (1) a continuation-in-part of U.S. patent application Ser. No. 10/601,106, filed Jun. 20, 2003; (2) a continuation-in-part of PCT Patent Application Serial No. PCT/US03/030633 filed Sep. 26, 2003 (now expired), which claims the benefit of priority to U.S. Provisional Application No. 60/414,117, filed Sep. 27, 2002, (now expired), U.S. Provisional Application No. 60/418,776, filed Oct. 16, 2002 (now expired) and U.S. Patent Application Ser. No. 60/419,425, filed Oct. 18, 2002 (now expired); (3) a continuation-in-part of PCT Patent Application No. PCT/US2003/029497, filed Sep. 17, 2003 (now expired), which claims the benefit of priority to U.S. Provisional Patent Application Ser. No. 60/412,290, filed Sep. 20, 2002 (now expired); and (4) a continuation-in-part of U.S. patent application Ser. No. 29/189,729, filed Sep. 10, 2003, now U.S. Pat. No. D517,812. The contents of the above-noted applications are each expressly incorporated herein by reference.

FIELD OF THE INVENTION

The present invention pertains to an oral care implement with a cleanser for cleaning soft tissue surfaces in the mouth.

BACKGROUND OF THE INVENTION

According to the American Dental Association, a major source of bad breath in healthy people is microbial deposits on the tongue, where a bacterial coating harbors organisms and debris that contribute to bad breath. The tongue is a haven for the growth of microorganisms since the papillary nature of the tongue surface creates a unique ecological site that provides an extremely large surface area, favoring the accumulation of oral bacteria. Anaerobic flora and bacteria residing on the tongue play an important role in the development of chronic bad breath commonly called halitosis. In general, the bacteria produce volatile sulfur compounds (VSC). If there is enough buildup of the sulfur compounds, the result can be lead bad breath or oral malodor.

While bladed tongue scrapers have been used in the past, these scrapers are inadequate in respect to their effectiveness on the soft tissue surface of the tongue. Broad flat scraping blades are limited in their ability to reach between the papillae where the bacteria and microdebris have collected. Moreover, notwithstanding the benefits to be gained by any ability to clean the tongue, some users avoid the use of such blades because of lack of comfort on the tongue surface.

Hence, there is a need for an oral care implement with a tongue cleanser that provides effective removal of the tongue bacteria and other debris while maintaining comfort to the user.

SUMMARY OF THE INVENTION

The invention pertains to an oral care implement with a tissue cleanser that provides improved cleaning and effective removal of bacteria and microdebris disposed on the oral tissue surfaces.

In one aspect, the invention can be an oral care implement comprising: a head and a handle; a plurality of tooth cleaning elements extending from a first face of the head; a receiving cavity formed into a second face of the head opposite the first face; a soft tissue cleanser formed of an elastomeric material that is injection molded into the receiving cavity, the soft tissue cleanser comprising a plurality of projections; and one or more peg members extending from a lower base surface of the receiving cavity, the soft tissue cleanser comprising one or more complementary apertures that receive the one or more peg members and expose tops of the one or more peg members.

In another aspect, the invention can be an oral care implement comprising: a head and a handle; a plurality of tooth cleaning elements extending from a first face of the head; a receiving cavity formed into a second face of the head opposite the first face; and a soft tissue cleanser formed of an elastomeric material that is injection molded into the receiving cavity to bond the soft tissue cleanser to the head, the soft tissue cleanser comprising a plurality of projections extending beyond the second face of the head.

In yet another aspect, the invention can be an oral care implement comprising: a handle; a head having a longitudinal axis; a plurality of tooth cleaning elements extending from a first face of the head; a receiving cavity formed into a second face of the head opposite the first face, the receiving cavity comprising a peripheral sidewall extending away from a lower base surface; a soft tissue cleanser formed of an elastomeric material that is injection molded into the receiving cavity to bond the soft tissue cleanser to the head, the soft tissue cleanser comprising a plurality of nubs that extend beyond the second face of the head; and at least one peg member aligned along the longitudinal axis and extending from the lower base surface of the receiving cavity, the soft tissue cleanser comprising at least one complementary aperture that exposes a top of the at least one peg member.

In an even further aspect, the invention can be an oral care implement comprising: a head and a handle; a plurality of tooth cleaning elements extending from a first face of the head; a soft tissue cleanser on the head opposite the first face, the soft tissue cleanser formed of an elastomeric material that is injection molded to the head to bond the soft tissue cleanser to the head, the soft tissue cleanser comprising a plurality of projections; and at least one peg member aligned along the longitudinal axis and extending from the head, the soft tissue cleanser comprising at least one complementary aperture that exposes a top of the at least one peg member

Further areas of applicability of the present invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention and the advantages thereof may be acquired by referring to the following description in consideration of the accompanying drawings, in which like reference numbers indicate like features, and wherein:

FIG. 1 is an exploded assembly perspective view of an oral care implement according to one or more aspects of an illustrative embodiment;

FIG. 2 is an enlarged perspective view of a head of an oral care implement of FIG. 1;

FIG. 3 is a plan view of the oral care implement of FIG. 1 illustrating a tongue cleaning feature;

FIG. 4 is a partial section view of a head of the oral care implement of FIG. 1 taken along line 4-4 of FIG. 3;

FIG. 5 is a plan view of the oral care implement of FIG. 1 illustrating at least one tooth cleaning configuration;

FIG. 6 is a perspective of the view of the oral care implement illustrating example tooth cleaning elements; and

FIG. 7 is a section view of an alternative construction of the head of an oral care implement.

DETAILED DESCRIPTION OF THE INVENTION

The following description of the preferred embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses.

In the following description, the invention is discussed in terms of a toothbrush, but could be in the form of other oral care implements including simply a tissue cleansing implement. Further, it is to be understood that other embodiments may be utilized and structural and functional modifications may be made without departing from the scope of the present invention.

FIGS. 1-7 illustrate an oral care implement, such as a toothbrush 100, having a handle 103 and a head 105 which may be used for cleaning the teeth and soft tissue in the mouth, such as the tongue, interior surfaces of the cheeks, lips or the gums. Handle 103 is provided for the user to readily grip and manipulate the toothbrush, and may be formed of many different shapes and constructions. While the head is normally widened relative to the neck of the handle, it could in some constructions simply be a continuous extension or narrowing of the handle. In the preferred construction, head 105 has a first face 106 that supports tooth cleaning elements 107 (FIGS. 5 and 6) and a second face 108 that supports a tissue cleanser 300 (FIGS. 2 and 3). The first and second faces 106, 108 are preferably on opposite sides of head 105. Nevertheless, tissue cleanser 300 may be mounted elsewhere, such as the proximal end 104 of handle 103. The tissue cleanser 300 or portions of it may also be located on the peripheral sidewall surface 101 of head 105 or extend farther towards the proximate end 104 of handle 103 than illustrated.

The elastomeric material of tissue cleanser 300 may be any biocompatible resilient material suitable for uses in an oral hygiene apparatus. To provide optimum comfort as well as cleaning benefits, the elastomeric material preferably has a hardness property in the range of A8 to A25 Shore hardness. As an example, one preferred elastomeric material is styrene-ethylene/butylene-styrene block copolymer (SEBS) manufactured by GLS Corporation. Nevertheless, SEBS material from other manufacturers or other materials within and outside the noted hardness range could be used.

Tissue cleanser 300 is preferably configured with a multiplicity of tissue engaging elements 303 (FIGS. 1-4), which in the preferred construction are formed as nubs. As used herein a “nub” is generally meant to include a column-like protrusion (without limitation to the cross-sectional shape of the protrusion) which is upstanding from a base surface. In a general sense, the nub, in the preferred construction, has a height that is greater than the width at the base of the nub (as measured in the longest direction). Nevertheless, nubs could include projections wherein the widths and heights are roughly the same or wherein the heights are somewhat smaller than the base widths. Moreover, in some circumstances (e.g., where the nub tapers to a tip or includes a base portion that narrows to a smaller projection) the base width can be substantially larger than the height.

Such tissue engaging elements 303 are designed to significantly reduce a major source of bad breath in people and improve hygiene. Nubs 303 enable removal of microflora and other debris from the tongue and other soft tissue surfaces within the mouth. The tongue, in particular, is prone to develop bacterial coatings that are known to harbor organisms and debris that can contribute to bad breath. This microflora can be found in the recesses between the papillae on most of the tongue's upper surface as well as along other soft tissue surfaces in the mouth. When engaged or otherwise pulled against a tongue surface, for example, nubs 303 of elastomeric tissue cleanser 300 provide for gentle engagement with the soft tissue while reaching downward into the recesses of adjacent papillae of the tongue. The elastomeric construction of tissue cleanser 300 also enables the base surface 301 to follow the natural contours of the oral tissue surfaces, such as the tongue, cheeks, lips, and gums of a user. Moreover, the soft nubs 303 are able to flex as needed to traverse and clean the soft tissue surfaces in the mouth along which it is moved.

As seen in FIGS. 2 and 4, in one preferred arrangement of tissue cleanser 300, nubs 303 are preferably conically shaped. As used herein, “conically shaped” or “conical” is meant to include true cones, frusto-conically shaped elements, and other shapes that taper to a narrow end and thereby resemble a cone irrespective of whether they are uniform, continuous in their taper, or have rounded cross-sections. With reference to FIG. 4, the base portion 305 of each conically shaped tissue engaging element 303 is larger than the corresponding tip portion 307. In this conically shaped configuration, the base portion 305 has a wider cross-sectional area to provide effective shear strength to withstand the lateral movement of the tissue cleanser 300 along the surface of the tongue or other soft tissue surface. The smaller width or diameter of the tip portion 307 in conjunction with the length of the conically shaped nub 303 enable the nubs to sweep into the recesses of the tongue and other surfaces to clean the microbial deposits and other debris from the soft tissue surfaces. In the preferred construction, nubs 303 are able to flex and bend from their respective vertical axes as lateral pressure is applied during use. This flexing enhances the comfort and cleaning of the soft tissue surfaces. In a preferred construction, the thickness or width of the base of the nub in 0.64 mm, and preferably within the range from about 0.51 mm to about 2.00 mm. Tip 307 of the nubs is 0.127 mm and preferably within that range from about 0.10 mm to about 0.75 mm for optimal penetration between the recesses of papillae of a user's tongue. The length or height of nubs 303, as measured from base surface 301 to tip 307, is preferably 0.91 mm and preferably within range from about 0.5 mm to about 2.5 mm, and most preferably range between 0.75 mm to 1.5 mm. Nevertheless, nubs of other sizes and shapes outside the given ranges can be used.

Alternatively, the tissue cleaning elements 303 may have other shapes. As one example, the tissue cleanser may have a grated form such as described in co-pending U.S. patent application Ser. No. 10/601,106, incorporated herein by reference.

In a preferred construction, nubs 303 are disposed on the base surface 301 of tissue cleanser 300 in a high density pattern. Each nub 303 is preferably spaced apart from adjacent nubs 303 between a range of about 0.5 mm to about 3 mm; more preferably the spacing ranges between 0.7 mm to 2.5 mm, and most preferably between 1 mm to 2 mm. Nevertheless, other spacing ranges are possible. The surface density of the nubs 303 on base surface 301 ranges preferably from about 100 to about 600 nubs per square inch. In a more preferred construction of the tissue cleanser, the surface density may range from 200 to 500 nubs per square inch, and most preferably between 300 to 450 nubs per square inch. In one preferred example, tissue cleanser 300 includes about 400 nubs per square inch of surface area. The surface density features in conjunction with the height of the nubs 303 enables the tissue cleanser to provide enhanced cleaning of the soft tissue surfaces with improved comfort. Nonetheless, other surface densities are possible.

As seen in FIG. 3, nubs 303 are preferably disposed in longitudinal rows in a direction generally parallel to the longitudinal axis a-a. Further, nubs 303 are disposed in transverse rows R1, R2 on an axis parallel to base surface 301 and generally perpendicular to the longitudinal axis a-a. In one preferred construction, adjacent nubs 303 are provided on the base surface 301 in a staggered arrangement. For example, adjacent transverse rows of nubs R1 and R2 have nubs 303 that are not directly behind each other. A first nub is said herein to be “directly behind” second nub when it is located within the lateral bounds of the second nub extending in a longitudinal direction. This configuration enables improved cleaning of the soft tissue surfaces by facilitating the removal of microflora and other debris, and especially from the recesses of adjacent papillae of the tongue. Nonetheless, the nubs could be arranged randomly or in a myriad of different patterns.

Tongue cleanser 300 is preferably formed by being molded to head 105, although other manufacturing processes could be used. With reference to FIGS. 1 and 4, tissue cleanser 300 is preferably molded within a basin or a receiving cavity 111 in face 108 of head 105. The receiving cavity 111 has a lower base surface 113 and a peripheral sidewall 115 extending away from the lower base surface 113. In one mounting arrangement, nubs 303 of the tissue cleanser 300 are exposed for use with the base surface of the tissue cleanser 300 being flush or recessed relative to the surface 114 of the head. Nevertheless, other orientations are possible. Also, base surface 301 of the tissue cleanser could be embedded in head 105 or covered by another layer with nubs 303 projecting through appropriate openings.

As can be seen in FIGS. 1 and 4, face 108 also preferably includes one or more peg members 117 a-c disposed within basin 111. Peg members 117 form anchor points against the opposing mold to prevent the head from moving under the pressure of the injection molding. As a result, tissue cleanser 300 preferably includes one or more complementary apertures 311 a-c which exposes the tops of peg members 117 a-c. Although, the pegs are illustrated in alignment along the centerline of the head (e.g. longitudinal axis a-a), the pegs could have many different positions. Further, the pegs and basin are preferably both included with head 105, but either could be used without the other.

Alternatively, basin 111 and peg members 117 a-c may be provided to position and hold a previously molded tissue cleanser, although these constructions are not necessary to use such a previously molded tissue cleanser.

Peg members 117 a-c may take on a variety of shapes and lengths. With continued reference to the FIGS. 1 and 4, head 105 includes peg members 117 a-c extending away from the lower base surface 113 of basin 111 to the height of the peripheral sidewall 115. The peg members 117 a-c are shaped in the form of a cylinder, but other shapes and lengths of the peg members 117 a-c are possible. While the molding process would preferably bond the tissue cleanser to the head, the tissue cleanser could be preformed and attached by adhesive or other known means.

As shown in FIGS. 1-4, tissue cleanser 300 is preferably formed as a pad composed of a soft and pliable elastomeric material for comfortable cleaning and effective removal of bacteria and debris disposed on the surface of the tongue, other soft tissue in the mouth and even along the lips. The tissue cleanser 300 also provides effective massaging, stimulation and removal of bacteria, debris and epithelial cells from the surfaces of the tongue, cheeks, gums or lips.

In the preferred construction (FIGS. 1-6), tissue cleansers 300 may rub against the inside surfaces of the cheeks or lips, and on the sides of the tongue while the user brushes his or her teeth, and thus provide a desired massaging, stimulation and cleaning of various soft tissue surfaces within the mouth. For example, during brushing of the facial tooth surfaces, tissue cleanser 300 is disposed on the outer face 108 of head 105 to naturally rub against the oral surfaces of the cheek. As a result, enhanced cleaning is attained without additional cleaning steps. Further, some users may sense a stimulating tingle on the cheek surfaces that leads to a positive user reaction, and even enjoyment of the comfortable feel of the tissue cleanser along the soft tissues surfaces in the mouth. Tissue cleanser 300 may also be additionally rubbed on the cheeks, tongue, etc. as desired for further cleaning aside from the contact that may occur while brushing the teeth.

Referring to FIGS. 5 and 6, the tooth cleaning elements 107 of head 105 may include a variety of tooth cleaning elements which can be used for wiping, cleaning and massaging the user's teeth and gums. Any suitable form of tooth cleaning elements may be used. The term “tooth cleaning elements” is used in a generic sense which refers to filament bristles or elastomeric fingers or walls that have any desirable shape. In the illustrated example of FIG. 5, tooth cleaning elements 107 include distal tooth cleaning elements 203 a-b disposed at a distal tip 121 of head 105, peripheral tooth cleaning elements 205 a-l, longitudinal tooth cleaning elements 207 a-c disposed along longitudinal axis a-a, arcuate tooth cleaning elements 209 a-d and 211 a-b, and proximal cleaning elements 213 a,b. Tooth cleaning elements 205, 207, 211 and 213 are preferably provided as tufts of bristles whereas tooth cleaning elements 209 are preferably formed as elastomeric walls. Nevertheless, other forms and types of tooth cleaning elements may be used.

FIG. 7 illustrates a sectional view of an alternative arrangement of a head 400 of a toothbrush. Head 400 is similar in construction to head 105, except that tooth cleaning elements 209 a-d are integrally formed with tissue cleanser 300. To accomplish the alternative construction, head 400 has appropriately sized ports or openings 401 to allow the elastomeric material to flow through the head during an injection molding process. In this construction, tooth cleaning elements 209 a-d and tissue cleaner 300 are formed with the same elastomeric material. Thus, head 400 may include at least one elastomeric tooth cleaning element formed as a unitary member with tissue cleanser 300.

As various changes could be made in the above methods, compositions and structures without departing from the scope of the invention, it is intended that all matter contained in this application, including all mechanisms and/or modes of interaction described above, shall be interpreted as illustrative only and not limiting in any way the scope of the appended claims.

The following examples are set forth as representative of the improved operation of the present invention. These examples are not to be construed as limiting the scope of the invention.

EXAMPLE 1

The performance nature of a toothbrush can be measured using known oral malodor assessment methods. A study was conducted to evaluate the performance of a toothbrush provided with an elastomeric tissue cleanser having conically shaped nubs, such as the preferred construction of toothbrush 100 discussed above. Human test subjects participated in the study. There was a washout or normalization period prior to testing of about 7 days in which the test subjects brushed twice a day with a fluoride dental cream (see Table 1). After the washout period, the test subjects were asked to refrain from any oral hygiene (brushing, rinsing, and flossing), eating and drinking prior to oral testing. A baseline volatile sulfur compound (VSC) sample was taken from each of the test subjects. In the study for overnight odor control, the test subjects brushed their teeth for one minute with a fluoride dental cream (see Table 1) using toothbrush 100 provided with the above noted tissue cleanser 300. Subsequently, the subjects cleaned their tongue surface with the tissue engaging elements of the toothbrush for ten seconds. The test subjects slept overnight and returned for post treatment. VSC samples were taken at the ten-hour time point from the previous day cleaning In the illustrative example, use of the toothbrush reduced oral VSC about 60% versus brushing the teeth alone as measured from a baseline ten hours after use. The VSC readings were obtained by gas chromatography.

EXAMPLE 2

In another study of the above-noted toothbrush 100, there was a washout or normalization period prior to testing of about 7 days which the test subjects brushed twice a day with a fluoride dental cream (see Table 1). The test subjects were asked to refrain from any oral hygiene (brushing, rinsing, and flossing), eating and drinking before testing. After the washout period, the test subjects provided a baseline tongue bacteria sample by swabbing a side of the back of the tongue with a sterile cotton swab. The test subjects brushed their teeth with a fluoride dental cream (see Table 1) for one minute with the toothbrush having the above-noted tissue cleanser. Subsequently, the test subjects cleaned their tongue surface with a preferred construction of the tissue engaging elements 300 of the toothbrush 100 for ten seconds. Two hours after the cleaning of the tongue surface, a tongue bacteria sample was taken from a side of the back of the tongue with a cotton swab. In the illustrative example, use of the tissue engaging elements controlled more odor causing tongue bacteria than simply brushing the teeth alone. Use of the tissue cleanser 300 demonstrated a tongue bacteria log reduction of over 0.8 Log colony forming units/ml two hours after use on the tongue.

EXAMPLE 3

In another study of the above-noted toothbrush, a MTT assay was used to examine the viability of the epithelial cells collected from the oral cavity prior to and after the use of the toothbrush with the noted tissue cleanser. The MTT Assay was based on the enzymatic reduction of the tetrazolium salt MTT [3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl-tetrazoliumbromide+++] in living, metabolically active cells. The reaction was carried out in situ in test tubes, and the reaction product, a purple-colored formazan soluble in dimethylsulfoxide, was measured colormetrically using a multiwell plate reader. Advantageously, the MTT Assay offers a high degree of precision, ease of use, and suitability for the purpose for large scale chemosensitivity testing.

Following a 7-day washout period, the test subjects reported to a test site without prior eating, drinking, or performing oral hygiene. The test subjects provided salivary rinse samples by rinsing their oral cavity with 9 ml of sterile water for 10 seconds and then discharging the water from the rinse into a tube containing 10* sterile phosphate buffered saline (PBS) solution. The samples were refrigerated for approximately 30 minutes before the MTT Assay was run. The test subjects brushed their teeth under supervision for one minute using a fluoride dental cream (see Table 1) followed by 10 seconds of tongue cleaning with the tongue cleanser 300 of the preferred construction. Approximately 30 minutes after brushing and tongue cleaning, the test subjects provided a rinse sample in the manner described previously.

The pre-rinse samples and post-rinse samples were centrifuged for 15 minutes at about 3000 RPM. The supernatant, e.g., clear liquid, was removed and the pellet was resuspended in 2.5 mL of PBS. The samples were vortexed for 5 seconds, then 2.5 ml of MTT Solution was added. The samples were subsequently incubated in a gently shaking waterbath set at 37[deg.] C. for 2 hours. Following the 2 hour incubation period, the samples were centrifuged for 15 minutes at about 3000 RPM. The supernatatant was siphoned out and 3 mL of detergent (0.04 N Acid Isopropanol) was added to dissolve purple crystals. An increase or decrease in MTT conversion was spectrophotometrically quantified. From each sample, 200 [mu]l of each was added to 96 well plates and the optical density was measured at 570 nm and compared to a negative buffer control. In the illustrative example, one minute of brushing followed by 10 seconds of use of the tissue cleanser reduced oral epithelial cells about 72% as determined by a MTT assay protocol.

EXAMPLE 4

In another study, human test subjects provided baseline VSC samples via a Halimeter (TM) (i.e., a sulfide meter). A Halimeter (TM) uses an electrochemical, voltammetric sensor which generates a signal when it is exposed to VSC such as, sulfide and mercaptan gases and measures the concentration of hydrogen sulfide gas in parts per billion. The test subjects brushed their teeth under supervision for one minute with the preferred construction of a toothbrush having the above noted tissue cleanser. Then, the test subjects used the noted toothbrush to provide six strokes on the tongue surface. A subsequent VSC sample was taken from the test subjects two hours after the brushing stage. In this illustrative example, use of a toothbrush with the tissue cleanser reduced the measured VSC in the mouth odor over 35% from a baseline measured two hours after use.

EXAMPLE 5

In one other study, after a washout period, human test subjects rinsed their mouths with sterile water to provide a baseline sample for viable epithelial cell analysis with the MTT assay. The subjects brushed their teeth under supervision for one minute with the preferred construction of the toothbrush having the above-noted tissue cleanser. Then, the test subjects used the tissue cleanser to provide six strokes on the tongue surface. The test subjects provided a post rinse sample for analysis. The samples were tested and analyzed in the manner as discussed with respect to Example 3. In this example, use of the toothbrush reduced oral epithelial cells by about 92% from a baseline as determined by MTT assay protocol.

In the above noted examples, the subjects brushed their teeth using a fluoride dental cream with the formulation in Table 1.

TABLE 1 % wt. Ingredient 48.76% Dicalcium Phosphate Dihydrate 22.0063% Water 22.00% Glycerin 4.138% SO3 Sodium Laurl Sulfate base -29% 1.000% Sodium CMC - 7MF - Food Grade 0.89% 105 Dental Cream Flavor 0.76% Sodium Monoflurophosphate 0.25% Tetrasodium Pyrophosphate 0.20% Sodium Saccharin

As used throughout, ranges are used as shorthand for describing each and every value that is within the range. Any value within the range can be selected as the terminus of the range. In addition, all references cited herein are hereby incorporated by referenced in their entireties. In the event of a conflict in a definition in the present disclosure and that of a cited reference, the present disclosure controls. 

What is claimed is:
 1. An oral care implement comprising: a head and a handle, the head having a longitudinal axis, a first face, and a second face opposite the first face; a soft tissue cleanser positioned on the second face of the head, the soft tissue cleanser comprising a pad formed of an elastomeric material, at least one aperture extending through the pad; and at least one protuberance extending from the second face of the head, the at least one protuberance extending into the aperture.
 2. The oral care implement according to claim 1 wherein the aperture and the protuberance are positioned on the longitudinal axis of the head.
 3. The oral care implement according to claim 2 wherein the protuberance is exposed through the aperture.
 4. The oral care implement according to claim 3 wherein a top surface of the protuberance is free of elastomer.
 5. The oral care implement according to claim 4 further comprising a plurality of projections extending beyond an outer surface of the pad.
 6. The oral care implement according to claim 5 wherein the plurality of projections are formed integrally with the pad out of the elastomeric material.
 7. The oral care implement according to claim 6 wherein a first group of the plurality of projections is located between the protuberance and a distal end of the head.
 8. The oral care implement according to claim 7 wherein a second group of the plurality of projections is located between the protuberance and opposing lateral sides of the head.
 9. The oral care implement according to claim 8 wherein a third group of the plurality of projections is located between the protuberance and a proximal end of the head.
 10. The oral care implement according to claim 9 wherein the protuberance is located centrally between the proximal and distal ends of the head and between the opposing lateral sides of the head.
 11. The oral care implement according to claim 10 wherein a top surface of the protuberance is flush with a front surface of the pad.
 12. The oral care implement according to claim 11 wherein the pad of the soft tissue cleanser surrounds the protuberance.
 13. The oral care implement according to claim 1 wherein the pad is injection molded onto the second face of the head to bond the pad to the head.
 14. The oral care implement according to claim 1 wherein the head further comprises a peripheral side surface extending between the first and second faces of the head, wherein the pad has a peripheral edge, and wherein a portion of the second face of the head substantially surrounds the pad and extends between the peripheral edge of the pad and the peripheral side surface of the head.
 15. The oral care implement according to claim 1 further comprising a plurality of the apertures extending through the pad and a plurality of the protuberances extending from the second face of the head, each of the protuberances extending into one of the plurality of apertures.
 16. The oral care implement according to claim 15 wherein the plurality of apertures and the plurality of protuberances are aligned along the longitudinal axis of the head.
 17. The oral care implement according to claim 16 wherein each of the plurality of protuberances is exposed through the aperture within which the protuberance extends, a top surface of each of the protuberances being free of elastomer.
 18. The oral care implement according to claim 17 further comprising a plurality of projections extending beyond the second face of the head.
 19. The oral care implement according to claim 18 wherein at least some of the plurality of projections are located between a first protuberance of the plurality of protuberances and a second protuberance of the plurality of protuberances in a direction of the longitudinal axis.
 20. The oral care implement according to claim 18 wherein at least some of the plurality of projections are located between the plurality of protuberances and opposing first and second lateral edges of the head.
 21. The oral care implement according to claim 18 wherein the plurality of projections are arranged in longitudinal rows in a direction generally parallel to the longitudinal axis of the head.
 22. The oral care implement according to claim 18 wherein at least one of the plurality of projections is located between a distal-most one of the protuberances and a distal end of the head.
 23. The oral care implement according to claim 18 wherein the plurality of projections are formed integrally with the pad out of the elastomeric material, the plurality of projections extending from a front surface of the pad.
 24. The oral care implement according to claim 15 wherein a top surface of each of the plurality of protuberances is flush with a front surface of the pad.
 25. The oral care implement according to claim 1 further comprising an opening formed through the head and extending from the first face of the head to the second face of the head, and wherein a portion of the elastomeric material that is unitary with the pad extends into and through the opening in the head and forms a tooth cleaning element extending from the first face of the head.
 26. The oral care implement according to claim 1 wherein a top surface of the at least one protuberance is flush with a front surface of the pad.
 27. The oral care implement according to claim 26 wherein the at least one protuberance is positioned on the longitudinal axis of the head.
 28. The oral care implement according to claim 1 wherein the at least one protuberance is shaped in the form of a cylinder.
 29. An oral care implement comprising: a head and a handle, the head having a longitudinal axis, a first face, and a second face opposite the first face; a plurality of tooth cleaning elements extending from the first face of the head; at least one protuberance extending from the second face of the head; and a soft tissue cleanser positioned on the second face of the head, the soft tissue cleanser substantially surrounding the protuberance.
 30. The oral care implement according to claim 29 wherein the soft tissue cleaner has an exposed outer surface, and wherein a top surface of the protuberance is flush with the exposed outer surface of the soft tissue cleaner.
 31. The oral care implement according to claim 30 further comprising a plurality of projections extending beyond the exposed outer surface of the soft tissue cleaner.
 32. The oral care implement according to claim 31 wherein the plurality of projections are formed integrally with the soft tissue cleanser out of an elastomeric material.
 33. The oral care implement according to claim 32 wherein the plurality of projections substantially surround the protuberance.
 34. The oral care implement according to claim 33 wherein the at least one protuberance is located on the longitudinal axis of the head.
 35. The oral care implement according to claim 34 wherein a top surface of the at least one protuberance is exposed and is free of elastomer.
 36. An oral care implement comprising: a head and a handle, the head having a longitudinal axis, a first face, and a second face opposite the first face; and a soft tissue cleanser positioned on the second face of the head, the soft tissue cleanser comprising a pad formed of an elastomeric material having at least one aperture extending therethrough and a plurality of projections extending beyond the second face of the head.
 37. The oral care implement according to claim 36 wherein the pad is injection molded onto the second face of the head to bond the pad to the head.
 38. The oral care implement according to claim 37 further comprising at least one protuberance extending from the second face of the head and through the aperture, at least a top surface of the protuberance being exposed.
 39. The oral care implement according to claim 38 wherein a first group of the plurality of projections is located between the protuberance and a distal end of the head.
 40. The oral care implement according to claim 39 wherein a second group of the plurality of projections is located between the protuberance and opposing lateral sides of the head.
 41. The oral care implement according to claim 40 wherein a third group of the plurality of projections is located between the protuberance and a proximal end of the head.
 42. The oral care implement according to claim 41 wherein the protuberance is located centrally between the proximal and distal ends of the head and between the opposing lateral sides of the head.
 43. The oral care implement according to claim 42 wherein a top surface of the protuberance is flush with a front surface of the pad.
 44. The oral care implement according to claim 43 wherein the plurality of projections are formed integrally with the pad out of the elastomeric material.
 45. The oral care implement according to claim 38 further comprising a plurality of the apertures extending through the soft tissue cleanser and a plurality of the protuberances extending from the second face of the head, each of the protuberances extending into one of the plurality of apertures, and wherein the plurality of apertures and the plurality of protuberances are aligned along the longitudinal axis of the head.
 46. The oral care implement according to claim 45 wherein at least some of the plurality of projections are located between a first protuberance of the plurality of protuberances and a second protuberance of the plurality of protuberances in a direction of the longitudinal axis.
 47. The oral care implement according to claim 45 wherein at least some of the plurality of projections are located between the plurality of protuberances and opposing first and second lateral edges of the head.
 48. The oral care implement according to claim 45 wherein the plurality of projections are arranged in longitudinal rows in a direction generally parallel to the longitudinal axis of the head.
 49. The oral care implement according to claim 45 wherein at least one of the plurality of projections is located between a distal-most one of the protuberances and a distal end of the head.
 50. The oral care implement according to claim 45 wherein the plurality of projections are formed integrally with the pad out of the elastomeric material, the plurality of projections extending from a front surface of the pad.
 51. The oral care implement according to claim 45 wherein a top surface of each of the plurality of protuberances is flush with a front surface of the pad, each of the plurality of projections extending beyond the front surface of the pad.
 52. The oral care implement according to claim 36 wherein the head further comprises a peripheral side surface extending between the first and second faces of the head, wherein the soft tissue cleanser has a peripheral edge, and wherein a portion of the second face of the head substantially surrounds the soft tissue cleanser and extends between the peripheral edge of the soft tissue cleanser and the peripheral side surface of the head.
 53. The oral care implement according to claim 36 wherein at least some of the plurality of projections are formed integrally with the pad and are positioned between the at least one aperture and a distal end of the head.
 54. An oral care implement comprising: a head and a handle, the head having a longitudinal axis, a first face, and a second face opposite the first face; a plurality of tooth cleaning elements extending from the front face of the head; a soft tissue cleanser positioned on the second face of the head, the soft tissue cleanser comprising a pad formed of an elastomeric material, a first surface of the pad being in contact with the second face of the head and a second surface of the pad being exposed, a plurality of projections formed integrally with the pad and extending outwardly from the second surface of the pad, at least one aperture extending through the pad; and at least one protuberance extending from the second face of the head, the at least one protuberance extending into the aperture so that the elastomeric material of the pad surrounds the protuberance, a top surface of the protuberance being substantially flush with an outer surface of the pad; wherein the aperture and the protuberance are positioned on the longitudinal axis of the head; wherein the plurality of projections includes a first group of projections located between the protuberance and a distal end of the head, a second group of projections located between the protuberance and opposing lateral sides of the head, and a third group of projections located between the protuberance and a proximal end of the head; and wherein the protuberance is located centrally between the proximal and distal ends of the head and between the opposing lateral sides of the head.
 55. The oral care implement according to claim 54 wherein the plurality of tooth cleaning elements includes at least one elastomeric tooth cleaning element that is formed as a unitary member with the soft tissue cleanser.
 56. A method of manufacturing an oral care implement comprising: forming a body comprising a handle and a head, the head having a first side, an opposite second side, and at least one protuberance extending upwardly from the second side of the head; injecting a resilient material onto the second side of the head to form a pad of a soft tissue cleanser, the pad of the soft tissue cleanser surrounding the protuberance so that the protuberance extends into an aperture of the pad.
 57. The method of claim 56 wherein the soft tissue cleanser further comprises a plurality of projections extending therefrom, the plurality of projections extending beyond an exposed outer surface of the pad.
 58. The method of claim 57 wherein the protuberance is located on a longitudinal axis of the head, and wherein the plurality of projections substantially surround the protuberance.
 59. The method of claim 56 further comprising a receiving cavity formed into the second face of the head, the receiving cavity comprising a peripheral sidewall extending from a floor of the receiving cavity, wherein the at least one protuberance extends from the floor of the receiving cavity, and wherein the resilient material is injected into the receiving cavity so that the peripheral sidewall substantially surrounds the pad. 